External Analytical Collaboration Lead – Biologics – Technical Operations
(Contract-to-Hire, Remote)
Position Summary:
Reporting to the Director of Operations, the External Analytical Collaboration Lead supports the Biologics Technical Operations Department for the late stage Phase III development program of a monoclonal antibody.
The External Collaboration Lead (ECL) has overall accountability for the successful oversight and management of all analytical deliverables via external partnerships. This can include one or more Contract Manufacturing Organizations (CMO’s), Contract Research Organizations (CRO’s), and/or Critical Suppliers, as assigned. The candidate will act as the primary contact and relationship manager to the specified External Partner(s). This includes the establishment and management of joint governance processes, escalations, steering committees, and issue / dispute resolution.
The External Collaboration Lead is accountable for all operational activities, including analytical method transfer, qualification and/or validation. Oversee tight timelines and accountable for end to end deliverables including , budgetary responsibility and oversight / monitoring of the External Partner’s performance against the project plan and risk management activities. The candidate will collaborate with SME’s and drive internal alignment on critical issues.
The External Collaboration Lead will lead and/or oversee technical transfers and launches at the respective CMO/CRO and manages technical changes in collaboration with the relevant internal functions. The candidate will own and maintain project schedules, budgets, risk logs, and provide support to organize internal / external CMC documents.
The candidate may perform other duties to support biologics CMC development and operations as appropriate.
Essential Duties and Responsibilities:
- Drive delivery objectives for a wide range of analytical methods including HPLC, CE, Micro, and Wet Chemistry.
- Lead relationships with CMO’s / CRO’s / Critical Suppliers and foster long-term collaboration.
- Support project management activities for process validation or analytical method validation at CMOs / CRO’s for drug substance and drug product manufacturing.
- Contribute to / lead price and contract negotiations for products, projects and services and supply agreements.
- Identifies, notifies and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationship.
- Facilitates the identification, prioritization, planning and execution of technical projects and ensures a successful and timely completion of deliverables
- Identifies supply constraints and leads timely resolution of issues.
- Build an executable plan for delivering project execution, timelines / milestones and accountability.
- Manage cross-collaboration among CMO’s / CRO’s / Critical Suppliers
- Drive on-time closure of Deviations, Change Controls and CAPAs
- Lead meetings with internal and/or external teams to facilitate project completion.
- Draft and manage minutes and track action items.
- Participates in and contributes to CMO / CRO selections, and evaluates a CMO’s / CRO’s capacity and capability as an input to a sourcing decision.
- Support Quality, Regulatory Affairs in preparing CMC section in regulatory filings.
- Oversee development of project plans aligned with strategic objectives.
- Monitors Key Performance Indicators, production campaigns and reports on CMO’s performance against plans, including negotiation of Quality and Supply improvement plans for adverse trend performance.
- Owns the collaboration’s budget and accrual process.
Qualifications:
- Bachelor’s degree in Biochemistry, Chemistry, Engineering or related life-science discipline, with 6-9 years of experience. Additional combinations of degrees and experience can be considered.
- Minimum 5 years of experience in CMO / CRO outsourcing model and Project Management
- Experience in cross-functional team management
- Experience and knowledge in monoclonal antibody analytics and drug development
- Knowledge of Smartsheet or other project management collaboration software
- Experience in biopharmaceutical method transfers and qualification
- Experience in recombinant protein submissions is desirable
- Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment.
- Must have excellent problem-solving skills, verbal and written communication skills.
- Proven ability to prioritize and manage multiple projects. Comfortable executing on multiple projects independently.
- Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues.